March 6, 2017 (Ft. Lauderdale, Florida)
Precision Medical Devices, Inc. (PMD) has just been granted an approval to expand its current implant series protocol to include a change out of its battery component in two of its current subjects wherein the batteries reached their end-of-charge life while another of its implants has been approved for a full device change out after that implant subject experiencing a break in its cable assembly.
This approval is helping PMD break new ground in its efforts to verify all features of its device technology work as designed while also providing an opportunity to obtain substantially longer observation timeframes on the most critical question related to the safety and efficacy of its product – the level of damage to the urethral tissue experienced by the device’s continued compression of the vessel.
The device has been designed to be able to exchange its control pack when the battery life ends, so allowing the Company to do such exchanges will demonstrate this design feature is working as designed.
Additionally, since the current battery system appears to have a useful life of about 7-8 months, by allowing the exchange and replacement of these battery components, the Company will have the opportunity of potentially extending out the observation period related to compressing the urethra to over a year, which will go a long way toward collecting enough data to establish how well the Company’s device technology is managing its impact on the urethra.
This protocol update could result in the Company having to do fewer additional animal implant tests and could also result in obtaining faster approvals to move to human implant trials.
The device component exchanges will be scheduled as soon as our surgical team schedules permit, and we will be reporting further on the progress of these implants.